Duns Number:039576871
Device Description: LEUTHARDT GRID HOLE PUNCH
Catalog Number
2105-9
Brand Name
PMT® CORPORATION
Version/Model Number
2105-9
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HAO
Product Code Name
Instrument, Surgical, Non-Powered
Public Device Record Key
00b0a0a9-6f20-4834-b321-4ee80b702ff8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 28, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 673 |
2 | A medical device with a moderate to high risk that requires special controls. | 8273 |
U | Unclassified | 1188 |